Proposed Charge to the CBER Post-marketing Safety Review Subcommittee
Post-market safety evaluation of CBER regulated biologic products (vaccines, allergenic products, blood, blood components, and blood derivatives, tissues, and cellular and gene therapies) is a core FDA/CBER function. CBER’s program uses several processes, methodologies and data sources to detect, characterize and evaluate adverse events associated with CBER regulated biologic products. To improve CBER’s ability to evaluate the safety of CBER regulated products in use, since 2008 CBER has embarked on an integrated program that includes improving access to population-based data for safety surveillance and epidemiological studies, while at the same time launching research to develop and evaluate new methods ranging from the efficient assessment of spontaneous reports to conducting near real time safety surveillance in claims-based healthcare systems. CBER is developing the Post-licensure Rapid Immunization Safety Monitoring (PRISM) program and the Blood Safety Continuous Active Surveillance Network (BloodScan) under the FDA’s mini-sentinel project in response to the requirement for an active surveillance network in the FDA Amendment Act (FDAAA) of 2007. CBER also established the Genomics Evaluation Team for Safety to encourage the use of genomics data to improve biologic product safety. As part of this effort CBER has sponsored several genomic studies.
Proposed Charge to the FDA Science Board: The FDA Science Board is charged with conducting a review of CBER's current and planned post-marketing safety practices. Review objectives include:
- Review the current processes and analysis tools FDA/CBER uses for identifying safety signals for CBER regulated products in FDA spontaneous reporting systems, especially the Vaccine Adverse Event Reporting System (VAERS) and the Adverse Event Reporting System (AERS).
- Review the current and potential approaches FDA/CBER is taking to improve the use of population-based healthcare databases for both safety surveillance and hypothesis testing studies, including the FDA/CBER’s mini-sentinel projects, PRISM and BloodScan; collaborative activities with other government agencies including CMS and CDC; and special studies with private health care providers.
- Review FDA/CBER’s efforts to use genomic and other “omic” data from the post-marketing period to improve the safety of CBER regulated products, especially vaccines.
- Evaluate FDA/CBER’s efforts to develop and evaluate novel methodological approaches in the post-marketing safety areas outlined above.